A Double-blind, Randomized, Placebo-controlled, Cross-over Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of Alginate Oligosaccharide (OligoG) Administered for 28 Days in Subjects With Cystic Fibrosis Chronically Colonised With Pseudomonas Aeruginosa

AlgiPharma AS3 sites in 2 countries26 target enrollmentMay 2011

ConditionsCystic Fibrosis

InterventionsOligoG CF-5/20 Saline

DrugsOligoG CF-5/20 Saline

Overview

Phase: Phase 1
Intervention: OligoG CF-5/20
Conditions: Cystic Fibrosis
Sponsor: AlgiPharma AS
Enrollment: 26
Locations: 3
Primary Endpoint: Safety and local tolerability of multiple dose administration of inhaled OligoG in Cystic Fibrosis subjects.
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to determine the safety and local tolerability of multiple dose administration of inhaled OligoG in CF subjects. Particular emphasis will be put on local, clinical tolerance, pulmonary function and pulmonary adverse events. The secondary purpose is to monitor the effect of multiple dose administration of inhaled OligoG on various efficacy variables, such as mucolytic activity, lung function, respiratory symptoms, Quality-of-Life and microbiological outcome measures.

Registry

clinicaltrials.gov

Start Date

May 2011

End Date

November 2013

Last Updated

11 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

AlgiPharma AS

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female with a confirmed diagnosis of cystic fibrosis defined by:
•Clinical features consistent with the diagnosis of CF \[(Rosenstein BJ and Cutting GR 1998)\]; AND
•Sweat chloride ≥60 mmol/L by pilocarpine iontophoresis; OR
•Genotypic confirmation of CFTR mutation
•Aged 18 years or older
•Ability to provide samples for microbiological evaluation throughout the study. Note: sputum samples are preferred however cough swabs may be performed on occasions where sputum cannot be collected.
•Positive microbiological finding of Pseudomonas aeruginosa in expectorated sputum or cough swab documented within 24 months prior to Screening (Visit 1).
•FEV1 must, at Screening (Visit 1), be between 35%-80% of the predicted normal value following adjustment for age, gender, and height according to the Knudson equation \[(Knudson RJ., Lebowitz MD., et al 1983)\].
•At Screening (Visit 1), no clinical or laboratory findings suggestive of significant pulmonary illness, other than CF, which in the opinion of the investigator would preclude participation in the study.
•Female subjects of child bearing potential and male subjects participating in the study who are sexually active must use acceptable contraception. Female subjects documented as being of non child-bearing potential (Section 4.2.8) are exempt from the contraceptive requirements. For the purpose of this study acceptable contraception is defined as:

Exclusion Criteria

•Changes in underlying therapy (e.g., pulmonary massage therapy, bronchodilators, NSAIDs, antibiotic agents, pancreatic enzyme preparations, nutritional supplements and DNase within the 21 days prior to Day 1 (Visit 2). Subjects must be willing to remain on the same underlying stable therapy regimens for the duration of the study until the final follow-up visit at Day
•Changes in physiotherapy technique or schedule within 14 days prior to Day 1 (Visit 2).
•Prohibited medications within 7 days prior to Day 1 (Visit 2). Prohibited medications are described in Section 5.6
•Pulmonary exacerbation within 28 days of Screening (Visit 1).
•Positive microbiological finding of Burkholderia sp. in expectorated sputum or cough swab documented within 12 months prior to Screening (Visit 1).
•On-going acute illness. Subjects must not have needed an outpatient visit, hospitalization or required any change in therapy for other pulmonary disease between Screening (Visit 1) and Day 1 (Visit 2).
•History of, or planned organ transplantation.
•Allergic bronchopulmonary aspergillosis (ABPA) in the last 12 months prior to Screening (Visit 1), defined as having received treatment for ABPA.
•Requirement for continuous (24 hour/day) oxygen supplementation.
•Concomitant administration of inhaled mannitol or hypertonic saline within 7 days prior to Day 1 (Visit 2).